Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fresh Autologous whole Blood, Standard of Care Expectant management of bleeding.
- Who it may be relevant to
- Registry conditions: Cardiac Disease, Bleeding Postoperative. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Targeted Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial.
Overview
Autologous blood transfused at the end of cardiopulmonary bypass will reduce total blood loss 24 hours after surgery and improve mitochondrial oxygen delivery measured by plasma succinate levels. The study design is a prospective randomized interventional trial of transfusion of fresh autologous whole blood versus standard of care expectant management of bleeding during elective cardiac surgery.
Detailed description
Cardiac surgery carries a significant risk of bleeding requiring transfusion of stored blood products and blood transfusion associated with cardiac surgery consumes 20% of the blood supply worldwide. Although transfusion may be life-saving, significant risks of complications such as lung injury or even an increase in mortality are associated with transfusion. Decreasing transfusion requirements during cardiac surgery has the potential to reduce the rate of complications, improve patient outcomes, and reduce cost resulting in increased value for both the patient and the health system as a whole. Collection of autologous blood before cardiopulmonary bypass (CPB) for transfusion after CPB has been shown to be both safe and effective for reducing blood loss during cardiac surgery, but this intervention has not been targeted to a patient population at high risk for bleeding and transfusion. Fresh whole blood has the capacity to restore coagulation system function during profound coagulopathy in a trauma setting or following massive transfusion by an unknown mechanism. One unit of fresh whole blood is able to restore clotting function equivalent to that achieved by 10 units of pooled platelets. Autologous whole blood collection prior to CPB for transfusion post-operatively has been shown to improve coagulation and decrease clot lysis but is not routinely performed because 90% to 95% of patients do not have extensive blood loss and subsequent coagulopathy. Coupling accurate pre-operative bleeding risk prediction with autologous fresh whole blood collection for transfusion after CPB would target an established, low cost, low risk intervention to an at risk patient population who may experience significant benefit.
Interventions
- Other Fresh Autologous whole Blood
Subjects randomized this arm will receive fresh autologous whole blood - Other Standard of Care Expectant management of bleeding
the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products
Primary outcome measures
- Estimated Blood Loss [Time frame: Within 24 hours after surgery]
Secondary outcome measures (12)
- Number of allogenic transfusions given [Time frame: 31 days]
- Severity of peri-operative stroke [Time frame: 31 days]
- Incident of peri-operative stroke [Time frame: 31 days]
- Development of Post-operative delirium [Time frame: 31 days]
- Development of Myocardial Infarction [Time frame: 31 days]
- Development of Heart failure [Time frame: 31 days]
- Detection of New Onset Atrial fibrillation [Time frame: 31 days]
- Development of Lung injury [Time frame: 31 days]
- Time to extubation [Time frame: 31 days]
- Development of Acute Kidney Injury [Time frame: 31 days]
- Initiation of renal replacement therapy [Time frame: 31 days]
- ICU length of stay [Time frame: 31 days]
Eligibility criteria
Inclusion criteria
- Adult subjects aged 18 to 90
- Able to provide informed consent
- Willing to accept autologous or allogenic blood transfusion
- Scheduled for elective cardiac surgery with cardiopulmonary bypass
Exclusion criteria
- Pre-operative administration of allogenic blood bank products in the previous 3 months
- Hemodynamically unstable defined as a systolic blood pressure less than 90 mmHg with a heart rate greater 100 or requiring intravenous vasopressor medications
- Significant active infection or sepsis defined by positive blood culture or positive wound culture
- Hemoglobin less than 7 g/dl
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Colorado Hospital — Aurora
Identifiers
NCT: NCT03204357 · 16-2647